Phase 4
Completed N=638
A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02688933 ↗Enrolled (actual)
638
Serious AEs
4.9%
Results posted
Aug 2018
Primary outcomePrimary: Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM — 55.40; 55.18 percentage of time — p=0.8494
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Primary Objective:
To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus.
Secondary Objective:
To demonstrate that treatment with HOE901-U300 compared to Lantus provides:
* Lower incidence rate of nocturnal symptomatic hypoglycemia;
* Better glucose control coverage during the last hours of CGM before next basal-insulin dosing;
* Less variability in CGM profile.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM |
55.40; 55.18 | 0.8494 |
| SECONDARY Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia |
70.8; 68.3; 50.9; 54.1 | — |
| SECONDARY Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year |
11.38; 11.39; 4.99; 5.61 | — |
| SECONDARY Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16 |
-1.99; 5.67 | — |
| SECONDARY Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection |
36.49; 35.07 | — |
| SECONDARY Coefficient of Variation (CV%) in Mean CGM Glucose |
41.27; 40.72; 36.99; 36.23; 17.44; 17.53 | — |
Eligibility Criteria
Inclusion criteria
- Adult participants (male and female) with type 1 diabetes mellitus (T1DM).
- Signed written informed consent.
Exclusion criteria
- Age 70 years.
- Fasting c-peptide ≥0.3 nmol/L as per source document or central lab test at Visit 1.
- Glycated hemoglobin (HbA1c) ≤ 6.5 % or ≥ 10.0% via central lab test at Visit 1.
- Participants who experienced none of episode of documented symptomatic and/or severe hypoglycemia (as per the American Diabetes Association (ADA) classification) during the past month prior to screening.
- Participants who experienced >1 episode of severe hypoglycemia resulting in coma/seizures during the last 12 months before screening.
- Participants received less than 1 year treatment with basal plus mealtime insulin.
- Used any basal insulins other than long-acting insulin analogs (ie, Lantus, Toujeo, Levemir, and Tresiba) in the past 3 months before screening.
- Required >80 U/day basal insulin analogs or not on stable dose (±20% total dose) within 30 days prior to screening.
- Used fewer than 2 injections of rapid-acting insulin analog per day within 30 days prior to screening.
- Used human regular insulin as mealtime insulin within 30 days prior to screening.
- Used an insulin pump during the last 6 months before screening.
- History of unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to required treatment (e.g., laser, surgical treatment, or injectable drugs) during the study period.
- Pregnant or breast-feeding women or planned pregnancy during the duration of the study.
- Use of any other investigational drug(s) within 1 month or 5 half-lives, whichever was longer prior to screening.
- Inappropriate CGM use during screening period evidenced by failure to obtain a minimum of 4 days of usable records by the end of screening.
- Noncompliance with self-monitored plasma glucose (SMPG) performance evidenced by failure to demonstrate at least 5 days of 5 point SMPG records by the end of screening.
The above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT02688933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.